To determine whether supplementation with oral Vitamin K and or low dose colchicine vs placebo will reduce vascular calcification activity in patients with diabetes mellitus. The ViKCoVac Diabetes Study.

Phase 4

Active, not recruiting

• Conditions: Diabetes Mellitus; Coronary Artery Disease; Cardiovascular - Coronary heart disease; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12616000024448
• Lead Sponsor: Royal Perth Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-01-15
• Last Update Posted: 28 June 2021

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 154

Inclusion Criteria

Type 1 or type 2 diabetes mellitus

Exclusion Criteria

Prior or planned treated with coronary bypass surgery or percutaneous coronary intervention.
Symptomatic coronary disease
Advanced renal disease
Known intolerance to Vit K or colchicine
Existing treatment with warfarin or another Vit K
Active cancer
Arrhythmia that precludes ECG gated PET/CT
Pregnancy
Hyperthyroidism
Current treatment for Paget' s disease,
Chronic inflammatory conditions requiring chronic intake of antibiotics,steroids or immunosupressant.
Chronic diarrhoea

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Vascular Calcification activity measured by PET scan[3 months]

Secondary Outcome Measures

Name	Time	Method
Secondary aims are to determine the rate of accumulation of vascular calcification measured as the difference on CT (between baseline and at 2 year follow up.) [2 years]